Prospective Birth Cohort Study Involving Environmental Uranium Exposure in the Navajo Nation

Forms and Documents

Document Name	Status
Home Environment Assessment Form and Instruction	New
Eligibility Screener Form	Modified
Postpartum Survey - 6, 9, 12 months Form	Modified
Postpartum Survey - 2 months Form	Modified
Food Frequency Questionnaire Form	Modified
Mullen Scales of Early Development Form	Modified
Ages and Stages Questionnaire Form	Modified
Enrollment Survey - father Form	Modified
Enrollment Survey - mother Form	Modified
Attach 18 Biomn Env Home Assmnt Rprt Ltrs.docx Supplementary Document	2013-02-13
Attach 16 Med Recd Abstrn Forms & Table 2-6-13.pdf Supplementary Document	2013-02-13
Attach 15 Biomonitoring SOPs.pdf Supplementary Document	2013-02-13
Attach 14 Biomon Table & Justification.docx Supplementary Document	2013-02-13
Attach 13 Survey Question Sources & Relevance.docx Supplementary Document	2013-02-13
Attach 12 MoP-Dvl Screen.pdf Supplementary Document	2013-02-13
Attach 11 Letters Support.pdf Supplementary Document	2013-02-13
Attach 10 Recruit Posters Brochure.doc Supplementary Document	2013-02-13
Attach 9 Timeline of Interactions.docx Supplementary Document	2013-02-13
Attach 8 Outreach Chronology.pdf Supplementary Document	2013-02-13
Attach 7 Indv Consult.docx Supplementary Document	2013-02-13
Attach 6 Study Info.doc Supplementary Document	2013-02-13
Attach 5 IRB Approval Letters.pdf Supplementary Document	2013-02-13
Attach 4 Consent Forms 2-6-13.docx Supplementary Document	2013-02-13
Attach 2 60 day FRN.pdf Supplementary Document	2013-02-13
Attach 1 Auth Legislation.docx Supplementary Document	2013-02-13
Navajo Supporting Stmt B.docx Supporting Statement B	2013-02-13
Navajo Supporting Stmt A.docx Supporting Statement A	2013-02-13

IC Document Collections

IC ID	Document Title	Status
205767	Home Environment Assessment Form and Instruction	New
201792	Eligibility Screener Form	Modified
201791	Postpartum Survey - 6, 9, 12 months Form	Modified
201790	Postpartum Survey - 2 months Form	Modified
201789	Food Frequency Questionnaire Form	Modified
201788	Mullen Scales of Early Development Form	Modified
201787	Ages and Stages Questionnaire Form	Modified
201786	Enrollment Survey - father Form	Modified
201785	Enrollment Survey - mother Form	Modified

ICR Details

OMB Control No: 0923-0046	ICR Reference No: 201302-0923-002
Status: Historical Active	Previous ICR Reference No: 201203-0923-003
Agency/Subagency: HHS/TSDR	Agency Tracking No: 18768
Title: Prospective Birth Cohort Study Involving Environmental Uranium Exposure in the Navajo Nation
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 02/14/2013
	Date Received in OIRA: 02/13/2013
Terms of Clearance: Approved consistent with CDC acknowledgment that the study design limits the extent to which it can determine the impacts of uranium exposure on birth outcomes and child development. As such CDC commits to: a) making sure that its contractors set realistic expectations with its study participants, including ensuring that all recruitment materials (e.g., YouTube videos and presentations at meetings) are consistent with the study goal of “improving CDC’s understanding of the relationship between exposures and health endpoints” rather than quantifying risk, and b) clearly articulating the limitations of the study design and, accordingly, of its conclusions when disseminating the findings to its stakeholders (including other Federal agencies, Congress, and the Navajo Nation).

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/29/2016	36 Months From Approved
Responses	7,400	0	0
Time Burden (Hours)	4,455	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Navajo Birth Cohort Study is the first prospective epidemiologic study of pregnancy and neonatal outcomes in a uranium-exposed population. The purpose of study is to quantify fetal risk from uranium exposure by recruiting Navajo mothers, assessing their uranium exposure at key developmental milestones, and following the children post-birth to evaluate any associations with birth defects or developmental delays. Additional research goals include assessing potential interactions with other heavy metals in the environment and determining activities and source contributions that lead to increased maternal/fetal uranium exposure. This will provide broad public health benefits for Navajo communities through outreach and education on the importance of prenatal care, environmental prenatal risks, and earlier assessment and referral for known developmental delays. Study partners include ATSDR, Univ. of New Mexico Community Environmental Health Program (UNM-CEHP), Navajo Area Indian Health Service (NAIHS), and Navajo Nation Division of Health (NNDOH).

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Authorizing Statute(s): US Code: 42 USC 9604 Name of Law: CERCLA
   US Code: 42 USC 9626 Name of Law: SARA (Superfund)
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 72206	11/22/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 18248	03/27/2012
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 9

IC Title	Form No.	Form Name
Enrollment Survey - mother	none	Enrollement Survey for Mothers
Enrollment Survey - father	none	Enrollment Survey for Fathers
Ages and Stages Questionnaire	none	Ages and Stages Questionnaires Inventory
Mullen Scales of Early Development	none	Mullen Scales of Early Learning Record Form
Food Frequency Questionnaire	none	Food Frequency Questionniare
Postpartum Survey - 2 months	none	Postpartum Survey for Mothers
Postpartum Survey - 6, 9, 12 months	none	Postpartum Survey for Mothers; 6, 9, and 12 months
Eligibility Screener	none	Eligibility Screener
Home Environment Assessment	none	Home Environmental Assessment

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	7,400	0	0	7,400	0	0
Annual Time Burden (Hours)	4,455	0	0	4,455	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a resubmission of a new ICR per OMB instructions.

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Annual Cost to Federal Government: $2,000,000

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 02/13/2013

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